In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Lipomin Drug Master File in Korea (Lipomin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lipomin. The MFDS reviews the Lipomin KDMF as part of the drug registration process and uses the information provided in the Lipomin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lipomin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lipomin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lipomin suppliers with KDMF on PharmaCompass.